The following data is part of a premarket notification filed by Philips Ultrasound, Inc. with the FDA for Cx50 3.0 Diagnostic Ultrasound System.
| Device ID | K123754 |
| 510k Number | K123754 |
| Device Name: | CX50 3.0 DIAGNOSTIC ULTRASOUND SYSTEM |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | PHILIPS ULTRASOUND, INC. 3000 MINUTEMAN RD. Andover, MA 01810 |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | IYN |
| Subsequent Product Code | ITX |
| Subsequent Product Code | IYO |
| CFR Regulation Number | 892.1550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2012-12-06 |
| Decision Date | 2012-12-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884838067851 | K123754 | 000 |
| 00884838061439 | K123754 | 000 |
| 00884838061514 | K123754 | 000 |
| 00884838061521 | K123754 | 000 |
| 00884838061538 | K123754 | 000 |
| 00884838061569 | K123754 | 000 |
| 00884838061583 | K123754 | 000 |
| 00884838061620 | K123754 | 000 |
| 00884838061637 | K123754 | 000 |
| 00884838067806 | K123754 | 000 |
| 00884838067813 | K123754 | 000 |
| 00884838025295 | K123754 | 000 |